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Wisest Elder Ever
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Join Date: Aug 2006
Location: Great Lakes
Posts: 33,508
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Wisest Elder Ever
Join Date: Aug 2006
Location: Great Lakes
Posts: 33,508
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yep,
and this is the second time. And may be the final one.
It was my understanding that the RX version would still be available:
Quote:
FDA Removes Unapproved Quinine Drugs From Market
Yael Waknine
Information from Industry
Antibiotic Treatment for Many Outpatient and Inpatient Bacterial InfectionsLearn more about high-dose, short-course therapy, including PK/PD parameters, clinical benefits, and doctor and patient benefits.
December 13, 2006 — The US Food and Drug Administration (FDA) has ordered the removal of unapproved drug products containing quinine, citing serious safety concerns and deaths associated with their use. The action is part of a larger effort to remove all unsafe, unapproved drugs from the market.
Since 1969, the FDA received 665 reports of serious adverse events (including 93 fatalities) associated with quinine use, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.
Serious adverse events have included cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions; potentially serious interactions with other drugs can also occur.
The FDA notes that only one quinine product (Qualaquin, made by Mutual Pharmaceutical Company, Inc) is currently approved by the FDA. Although indicated only for the treatment of uncomplicated Plasmodium falciparum malaria, the drug is often prescribed to treat leg cramps and similar conditions despite drug label warnings advising that the risks associated with its use in this setting outweigh potential benefits.
Unapproved quinine drug products are marketed without these drug label warnings, which increases the risk for their misuse and potential consumption of doses that have not been reviewed or approved by the FDA. Because of its narrow therapeutic index, quinine must be used carefully; dose modifications and/or close monitoring may be required for patients with hepatic or renal impairment.
Under the FDA order, all manufacturing of these products must cease within 60 days. However, some previously shipped merchandise may remain on pharmacy shelves for a short time. Consumers have been advised to contact their healthcare provider with any questions or concerns regarding their use of unapproved quinine products.
Adverse events potentially related to quinine therapy should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
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And this:
Quote:
Notice: Drug Products Containing Quinine; Enforcement Action Dates
Federal Register: December 15, 2006 (Volume 71, Number 241)
Page 75557-75560
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to take enforcement action against unapproved drug products
containing quinine (including quinine sulfate and any other salt of
quinine) and persons who cause the manufacture of such products or
their shipment in interstate commerce. Drug products containing
quinine, quinine sulfate, and any other salt of quinine are new drugs
that require approved applications. One firm has an approved
application to market a drug product containing quinine sulfate to
treat malaria; this product has been designated an orphan drug product.
Other manufacturers who wish to market a drug product containing
quinine, quinine sulfate, or any other salt of quinine must obtain FDA
approval of a new drug application (NDA) or an abbreviated new drug
application (ANDA); consideration of any such applications will be
subject to the rights of the current NDA holder under the Orphan Drug
Act.
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from http://www.pharmcast.com/FederalRegi...nine121506.htm
Given that quinine does not have a very large customer base, drug companies are not likely to go to the expense of a new drug application, which is very
expensive!
I have provided the second link for interested readers here..it goes into
quite a bit of detail. The benefits of quinine just don't outweigh the risks.
About Mutual's product:
Quote:
otice: Quinine Sulfate for the Treatment of Malaria Remains Available in the United States
On December 11, 2006, the Food and Drug Administration issued an order* to cease U.S. manufacturing of unapproved products containing quinine, including quinine sulfate and any other salt of quinine on or after February 13, 2007, and to cease shipping such products interstate on or after June 13, 2007. After these dates only FDA-approved quinine products may be manufactured and shipped interstate. However, there may continue to be some of these quinine products on pharmacy shelves until the expiration dates of these products are reached.
This action does not affect quinine drug products marketed with FDA approval. FDA has approved one quinine drug product* for the treatment of malaria, which is manufactured by Mutual Pharmaceutical Company, Inc. (Mutual), of Philadelphia, PA. It contains quinine sulfate as the active ingredient without any additional active ingredients in 324 mg capsules and is sold under the trade name Qualaquin (quinine sulfate) with the following NDC number: 13310-153-07. At this time, there is no evidence of any shortages or limited availability of quinine. If a pharmacy has difficulty obtaining Qualaquin, they may contact Mutual at 215-697-1900.
Additional details can be found on the FDA website at:
http://www.fda.gov/cder/drug/unappro...uinineQA.pdf.* (30 KB/5 pages)
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from http://www.cdc.gov/malaria/diagnosis...ailability.htm
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Weezie looking at petunias 8.25.2017
**************************** These forums are for mutual support and information sharing only. The forums are not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. Always consult your doctor before trying anything you read here.
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01-24-2007, 06:43 PM
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